12-03-2022  3:29 pm   •   PDX and SEA Weather
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NORTHWEST NEWS

Tough Oregon Gun Law Faces Legal Challenge, Could Be Delayed

Midterm voters narrowly passed one of the toughest gun control laws in the nation, but the new permit-to-purchase mandate and ban on high-capacity magazines faces a lawsuit that could put it on ice just days before it's set to take effect.

Portland Approves $27M for New Homeless Camps

Public opposition to the measure and the money that will fund it has been heated, with critics saying it will criminalize homelessness and fail to address its root causes.

Portland Settles Lawsuit Over Police Use of Tear Gas

The lawsuit was originally filed by Don't Shoot Portland in June 2020. “Our freedom of expression is the foundation of how we make social change possible,” Teressa Raiford said in a news release. “Black Lives Still Matter.”

Oregon Lawmakers Lift Security Measure Imposed on Senator

Since July 2019, Sen. Brian Boquist had been required to give 12 hours notice before coming to the Oregon State Capitol, to give the state police time to bolster their security and to ensure the safety of people in the Capitol.

NEWS BRIEFS

PBS Genealogy Show Seeks Viewers’ Brick Walls

The popular PBS show “Finding Your Roots” is putting out a nationwide casting call for a non-celebrity to be featured on season...

The James Museum Opens Black Pioneers: Legacy In The American West

This first-of-its-kind-exhibition explores Black history in the West with a timeline of pictorial quilts. ...

Use of Deadly Force Investigation Involving Clackamas County Sheriff and Oregon State Police Concludes

The grand jury’s role was solely to determine whether the involved officers’ conduct warranted criminal charges; questions...

Fan buying famed ‘Goonies’ house in Oregon, listed for jumi.7M

ASTORIA, Ore. (AP) — The listing agent for the Victorian home featured in the “The Goonies” film in Astoria, Oregon, said this week the likely new owner is a fan of the classic coming-of-age movie about friendships and treasure hunting, and he promises to preserve and protect the landmark. ...

Scientists call for action to help sunflower sea stars

ASTORIA, Ore. (AP) — Scientists along the West Coast are calling for action to help sunflower sea stars, among the largest sea stars in the world, recover from catastrophic population declines. Experts say a sea star wasting disease epidemic that began in 2013 has decimated about...

Missouri holds off Arkansas 29-27 to reach bowl eligibility

COLUMBIA, Mo. (AP) — Missouri and Arkansas will be headed to similar bowl games after the Tigers held off the Razorbacks 29-27 on Saturday night, leaving each of the bitter border rivals 6-6 on the season. Only one walked out of Faurot Field with victory cigars. Brady...

Rivalry week should bring SEC bowl forecast into clear focus

GAINESVILLE, Fla. (AP) — It’s rivalry week for most of the Southeastern Conference. The Egg Bowl. The Iron Bowl. The Palmetto Bowl. The Sunshine Showdown. Clean, Old-Fashioned Hate. The Battle Line Rivalry. It’s a chance for everyone to either avoid or add to the powerhouse...

OPINION

‘I Unreservedly Apologize’

The Oregonian commissioned a study of its history of racism, and published the report on Oct. 24, 2022. The Skanner is pleased to republish the apology written by the editor, Therese Bottomly. We hope other institutions will follow this example of looking...

City Officials Should Take Listening Lessons

Sisters of the Road share personal reflections of their staff after a town hall meeting at which people with lived experience of homelessness spoke ...

When Student Loan Repayments Resume, Will Problems Return Too?

HBCU borrowers question little loan forgiveness, delays to financial security ...

Tell the Supreme Court: We Still Need Affirmative Action

Opponents of affirmative action have been trying to destroy it for years. And now it looks like they just might get their chance. ...

AFRICAN AMERICANS IN THE NEWS

Antisemitic celebrities stoke fears of normalizing hate

A surge of anti-Jewish vitriol, spread by a world-famous rapper, an NBA star and other prominent people, is stoking fears that public figures are normalizing hate and ramping up the risk of violence in a country already experiencing a sharp increase in antisemitism. Leaders of the...

Both sides see high stakes in gay rights Supreme Court case

WASHINGTON (AP) — The Supreme Court is being warned about the potentially dire consequences of a case next week involving a Christian graphic artist who objects to designing wedding websites for same-sex couples. Rule for the designer and the justices will expose not only same-sex...

GOP's Duarte takes California Central Valley US House seat

LOS ANGELES (AP) — Republican John Duarte defeated Democrat Adam Gray on Friday in a new California U.S. House district in the Central Valley farm belt that produced the closest congressional contest in the state this year. With virtually all of the ballots counted, Duarte has just...

ENTERTAINMENT

Prince William, like his father, prioritizes the environment

BOSTON (AP) — Prince William capped a three-day visit to Boston by meeting with President Joe Biden to share his vision for safeguarding the environment before attending a gala event Friday evening where he sounded an optimistic tone about solving the world’s environmental problems through...

LGBTQ chorus in Colorado Springs unifies community with song

COLORADO SPRINGS, Colo. (AP) — Below the vaulted dome and dark wood beams of a church in Colorado Springs, a gay men's choir rehearsed for a concert that's taken on new meaning after an LGBTQ night club became the site of a shooting that killed five and wounded 17. “There is no...

Britney Spears' massive pop songs to land on Broadway, again

NEW YORK (AP) — A stage musical about woke princesses that uses hit songs by Britney Spears will land on Broadway this summer. "Once Upon a One More Time," featuring Spears' tunes, including “Oops!… I Did It Again,” “Lucky,” “Stronger” and “Toxic,” will start...

U.S. & WORLD NEWS

Polynesian pride: Three-day canoe voyage in mid-Pacific

RAPA NUI, Chile (AP) — The causes are worthy, the course is daunting – almost 500 kilometers (about 300 miles)...

Defeated election conspiracists seek to lead Michigan GOP

LANSING, Mich. (AP) — The Republicans who lost their races for Michigan's top three statewide offices after...

Messi scores, Argentina reaches World Cup quarterfinals

AL RAYYAN, Qatar (AP) — Lionel Messi was pushed into the middle of a joyous post-match huddle as Argentina’s...

AP PHOTOS: Residents face new reality in retaken Kherson

KHERSON, Ukraine (AP) — When Ukraine wrested back Kherson from Russian occupiers nearly a month ago, it was a...

Russia rejects -a-barrel cap on its oil, warns of cutoffs

KYIV, Ukraine (AP) — Russian authorities rejected a price cap on the country's oil set by Ukraine’s Western...

Thousands protest in South Korea in support of truckers

SEOUL, South Korea (AP) — Thousands of demonstrators representing organized labor marched in South Korea’s...

Linda A. Johnson AP Business Writer

TRENTON, N.J. (AP) -- Federal inspectors say the contract manufacturer for Johnson & Johnson's cancer drug Doxil hasn't been maintaining equipment or promptly investigating defective product batches and other serious problems at its Bedford, Ohio, factory.

The latest Food and Drug Administration inspection report details lax quality control, failure to follow standard procedures and even lack of follow-up about a container of urine found in the Ben Venue Laboratories Inc. facility, which makes sterile medicines.

Doxil is one of a record 251 medications reported unavailable or in short supply in the U.S. this year, most of them injected drugs crucial for hospital operations. The crisis, blamed on at least 15 deaths, is disrupting patient care and clinical testing of new drugs being compared to or combined with older drugs in short supply.

Ben Venue is the sole supplier for Doxil, which has been in short supply since early summer and is no longer available for new patients.

First approved in 1995, Doxil is used to treat ovarian cancer, the bone cancer multiple myeloma and an HIV-related cancer called Kaposi's sarcoma. Currently, only 2,000 U.S. patients are getting it, and another 2,240 are on a waiting list, according to New Brunswick, N.J.-based J&J.

Ben Venue, part of German drugmaker Boehringer Ingelheim, said three weeks ago that it was temporarily halting manufacture and distribution of all products made at the Bedford plant. It cited an internal review indicating that routine preventive maintenance and tests to ensure manufacturing equipment is operating properly "did not occur at the specified time interval and is overdue."

Ben Venue spokesman Jason Kurtz said Thursday in an e-mailed response to The AP that the company is "working diligently to assess and implement the appropriate corrective actions to address the observations of the FDA investigators."

"Our highest priority is the delivery of safe and effective products to patients," he wrote. "We are continuing to work closely with the FDA with the goal of bringing the products we make back to patients as quickly as possible."

The inspection report posted this week on the FDA's website, covering visits to the factory from Nov. 7 through Dec. 2, details numerous deficiencies not promptly resolved or reported to plant managers. Some problems labeled as "critical" by the factory's quality unit were downgraded to "major" without justification, and the plant's vice presidents for operations and quality were unaware of them when the FDA inspectors asked about them.

The report notes:

-An investigation was opened on Sept. 19 on a 10-gallon can, found in a storage area, that contained a liquid that testing later indicated was urine. Follow-up was "past-due" at the time of the FDA inspectors' visits. Kurtz wrote Thursday that the container of liquid "consistent with urine" was reported to local police and the investigation remains open.

--Monitoring of air samples in manufacturing areas identified microbial contaminants, but Ben Venue did not identify their sources.

-The company doesn't have data showing its "manufacturing process consistently produces product meeting an acceptable level of sterility assurance."

-As of four weeks ago, there were "approximately 107 required preventive maintenance activities" at least 30 days past their scheduled due date.

-Quality-control staff lacked the training, technical expertise and oversight to perform their duties.

Johnson & Johnson spokeswoman Lisa Vaga said J&J does not know when Ben Venue will again be able to ship Doxil, but it has been working on finding additional suppliers since the summer and has found an alternate. The transition will require "an extended period," she said.

Ben Venue announced on Aug. 18 that it would be transitioning out of contract manufacturing over the next several years. That decision followed a May report by FDA inspectors at the same factory stating that, despite complaints dating back to August 2006, the company still had not identified the cause of metal particles contaminating two products that had been distributed. The names of the products were blacked out in the report.

Johnson & Johnson warned doctors on June 21 that it anticipated a shortage of Doxil, which has no generic alternatives. In August, it started a rationing system to allocate Doxil as supplies became available to patients who had started treatment.

As the drug shortages have mounted, President Obama on Oct. 31 ordered the FDA to take several steps to resolve and prevent shortages. The FDA and several members of Congress have been holding hearings since September to identify reasons for and possible solutions to the shortages.

The causes include manufacturing deficiencies leading to production shutdowns, companies ending production of some drugs with tiny profit margins, consolidation in the generic drug industry and limited supplies of some ingredients.

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